NCT00869622

Brief Summary

Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel): Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone loss associated with the use of antiepileptic drugs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 24, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

6.3 years

First QC Date

March 25, 2009

Results QC Date

January 28, 2015

Last Update Submit

July 23, 2015

Conditions

EpilepsyBone LossOsteoporosisFractures

Keywords

osteoporosisbone mineral densityfractureantiepileptic drugseizurePrevention of bone lossPrevention of osteoporosisPrevention of Fractures

Outcome Measures

Primary Outcomes (1)

  • Changes in Bone Mineral Density

    Patients with a T-Score of \> -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D. Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals.

    2 years

Secondary Outcomes (1)

  • Vertebral Fractures

    2 years

Study Arms (2)

Risedronate

ACTIVE COMPARATOR

Active drug

Drug: Risedronate

Placebo + Calcium and Vitamin D

PLACEBO COMPARATOR

All patients both on placebo and active bisphosphonate to receive calcium and vitamin D

Drug: Placebo + Calcium and Vitamin D

Interventions

RisedronateDRUG

35 mgs/week + calcium and vit d

Also known as: Actonel
Risedronate
Placebo + Calcium and Vitamin DDRUG

sugar pill + calcium 1200mgs/day and vitamin d at least 800IU

Also known as: Placebo
Placebo + Calcium and Vitamin D

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male gender
  • Epilepsy
  • Anti-epileptic drug treatment with phenytoin, or phenobarbital or valproate sodium
  • Normal renal function and normal Vitamin D and calcium levels

You may not qualify if:

  • Female gender
  • Organ transplant
  • Use of oral glucocorticoids
  • Renal insufficiency (eGFR \< 30ml/min)
  • Severe swallowing disorder
  • Severe esophagitis
  • Patients taking sodium valproate for reasons other than epilepsy
  • Previous treatment with osteoporosis drugs such as bisphosphonates, calcitonin or PTH analog

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

EpilepsyBone Diseases, MetabolicOsteoporosisFractures, BoneSeizures

Interventions

Risedronic AcidCalciumVitamin D

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Antonio A. Lazzari, M.D., Ph.D
Organization
VA Boston Healthcare System
Antonio.Lazzari@va.gov
(857) 364-6381

Study Officials

  • Antonio A Lazzari, MD

    VA Boston HCS

    PRINCIPAL INVESTIGATOR

  • Phillip Dussault, Pharm D

    VA Boston HCS

    PRINCIPAL INVESTIGATOR

  • Manisha Thakore, MD

    VA Boston HCS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Osteoporosis Prevention and Treatment Center VABHCS

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

June 1, 2006

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

July 24, 2015

Results First Posted

July 24, 2015

Record last verified: 2015-07

Locations

US(1)